Placement of Foley balloon for cervical ripening without tension. for Induced Vaginal Delivery

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Texas Medical Branch, Galveston, TX
Induced Vaginal Delivery
Placement of Foley balloon for cervical ripening without tension. - Other
Eligibility
18 - 65
Female
What conditions do you have?
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Study Summary

Foley balloons are commonly used as a mechanical method of cervical ripening for induction of labor. Foley balloons may be placed either under tension or without tension (tension-free). The purpose of our study is to examine time to delivery in nulliparous women undergoing induction of labor who have a Foley balloon placed as a mechanical cervical dilator, assigned to either tension or without tension. The goal is to determine if there is a potential added benefit to placing the Foley balloon on tension as compared to no tension. Our hypothesis is that Foley balloon under tension for cervical ripening results in shorter time to vaginal delivery compared to Foley balloon placed without tension.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Induced Vaginal Delivery

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Placement of Foley balloon until delivery

Foley bulb placement to vaginal delivery (minutes)
Time to vaginal delivery
Hour 24
Incidence of postpartum hemorrhage
Placement of Foley balloon until cesarean delivery if applicable
Incidence of primary cesarean delivery
Placement of Foley balloon until delivery
Incidence of chorioamnionitis
Hour 12
Request for analgesia following placement of the Foley balloon

Trial Safety

Safety Progress

1 of 3

Other trials for Induced Vaginal Delivery

Trial Design

2 Treatment Groups

Tension
1 of 2
Without tension (tension free)
1 of 2
Active Control
Experimental Treatment

260 Total Participants · 2 Treatment Groups

Primary Treatment: Placement of Foley balloon for cervical ripening without tension. · No Placebo Group · N/A

Without tension (tension free)
Other
Experimental Group · 1 Intervention: Placement of Foley balloon for cervical ripening without tension. · Intervention Types: Other
Tension
Other
ActiveComparator Group · 1 Intervention: Placement of Foley balloon for cervical ripening with tension. · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: placement of foley balloon until delivery
Closest Location: University of Texas Medical Branch · Galveston, TX
Photo of texas 1Photo of texas 2Photo of texas 3
2011First Recorded Clinical Trial
1 TrialsResearching Induced Vaginal Delivery
323 CompletedClinical Trials

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
220 Previous Clinical Trials
54,853 Total Patients Enrolled
Meagan V Benson, DOPrincipal InvestigatorUniversity of Texas

Eligibility Criteria

Age 18 - 65 · Female Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a cervical exam less than 3 cm dilated and less than or equal to 60% effaced.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References